Determination of the Iodine Status in Pregnant Women in the Netherlands.

Healthy Clinical Trial

— JOZO  

Official title:

Determination of the Iodine Status in Pregnant Women in the Netherlands. Are Current Iodine Intake Recommendations Still Adequate?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT06412744
• Other study ID #: NL70677.068.19
• Secondary ID: NL8297
• Status: Terminated
• Start date: October 6, 2020
• Est. completion date: May 1, 2024

Study information

• Verified date: May 2024
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Study to determine iodine status in dutch pregnant women

Description:

Rationale: Adequate dietary iodine intake is essential to thyroid hormone synthesis, which is key for normal growth, development and metabolism. During pregnancy, maternal iodine needs are increased (recommended intake: 175 µg/day) and iodine deficiency during pregnancy affects brain and cognitive development of the foetus and might lead to pregnancy complications. Despite the use of iodized salt, it has been shown that iodine intake in the Netherlands is declining. Importantly, a recent small study in Groningen indicated a high prevalence of iodine deficiency during pregnancy (83% of participants) which was not completely restored by 16-week iodine supplementation (150 ug/d). Also in other Western European countries (i.e. Belgium, U.K., North Ireland, Sweden, Denmark and Austria) low median urinary concentrations of iodine (73-124 ug/L) have been observed in pregnant women. Notably, most studies collected spot-urine samples and a 24h urine collection, the golden standard for determination of iodine status, is lacking. Therefore, here it is proposed to measure 24h median urinary iodine concentration corrected for urinary volume and creatinin levels in pregnant women, and compare these values with Thyroglobulin (Tg)-concentrations in serum as measure for iodine intake over a longer period of time. It is hypothesised that the iodine status of pregnant women in The Netherlands is lower than the national recommended intake for this target group.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 43
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Female

• 18-45y old

• in first 16 weeks of pregnancy

• pregnant of singleton

Exclusion Criteria:

• Thyroid-disease or any other metabolic disease

• kidney disease

• twin-pregnancy

Related Conditions & MeSH terms

• Healthy
• Pregnancy Related

Locations

Country	Name	City	State
Netherlands	Maastricht UMC+	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	National Institute for Public Health and the Environment (RIVM)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median urinary iodine excretion (µg/d)	Median urinary iodine excretion (µg/d)	At baseline measurement
Secondary	Thyroglobulin and thyroglobulin antibody concentrations in blood serum	Thyroglobulin and thyroglobulin antibody concentrations in blood serum	At baseline measurement
Secondary	Creatinin concentration in urine	Creatinin concentration in urine	At baseline measurement
Secondary	Urinary volume	Urinary volume	At baseline measurement
Secondary	Smoking status (smoking is interfering with iodine metabolism)	Smoking status (smoking is interfering with iodine metabolism) Yes/no	At baseline measurement
Secondary	Vegan/Vegetarian y/n (soy is competitive for iodine on thyroid)	Vegan/Vegetarian y/n (soy is competitive for iodine on thyroid)	At baseline measurement
Secondary	Nutritional intake specifically related to iodine intake (questionnaire)	Nutritional intake specifically related to iodine intake (questionnaire) Iodine specific ffq	At baseline measurement
Secondary	Intake other relevant micronutrients for pregnant	Intake other relevant micronutrients for pregnant	At baseline measurement